Ureteral access sheath

ABSTRACT

A ureteral access sheath adapted for insertion into a urethra includes an elongate tube extending between a proximal end and a distal end. A handle assembly is disposed at the proximal end and includes enlarged portions which inhibit migration of the sheath into the urethra. The enlarged portions are shaped like the bell of a horn with a concave, distally-facing outer surface and a convex, proximally-facing inner surface. The inner surface functions as a funnel while the outer surface is sized and configured to receive adjacent fingers of a user&#39;s hand held in its natural position. In an associated method, this shape of the handle assembly facilitates maintaining the sheath in a stationary position during insertion and removal of instrumentation. The handle assembly can be movable on the tube to facilitate variation of the sheath link in situ.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.10/198,030, filed Jul. 17, 2002, which is a continuation-in-part of U.S.patent application Ser. No. 09/303,485, filed Apr. 30, 1999, now U.S.Pat. No. 6,471,684, the entire disclosures of which are herebyincorporated by reference as if set forth in full herein

FIELD OF THE INVENTION

This invention relates generally to guideways for endoluminal access andmore specifically to surgical access devices adapted to introducesurgical instrumentation into body conduits.

DISCUSSION OF THE PRIOR ART

Surgical access devices of the prior art typically include a sheathhaving an outside diameter and an inside diameter. An obturator ordilator is inserted into the sheath to facilitate introduction of thesheath into the body conduit. Once the sheath is positioned, theobturator is removed leaving a working channel for surgicalinstrumentation.

Particularly in the field of urology, the sheath has been provided inthe form of an elongate tube having an axis extending between a proximalend and a distal end. The diameter of the tube is generally constant,except for a reduced diameter segment at the distal end. Although theobturator has had an enlarged structure at its proximal end, there hasbeen no such enlargement for the sheath. This has presented a problem asthe sheath has tended to migrate distally and disappear beneath theurethral meatus. Representative of this art is the FLEXIBLE URETEROSCOPESHEATH manufactured and sold by Cook Urological Incorporated.

Access devices particularly adapted for other body conduits have hadenlargements at the proximal end, but these have not been specificallyconfigured to prevent migration or facilitate the introduction ofinstrumentation. Representative of this art are the “banana peel”sheaths which split axially for removal after catheter placement.

During the introduction and removal of dilators, obturators, andinstrumentation into and out of a sheath, it is always desirable tofacilitate maintenance of the sheath in a relatively stationaryorientation. In the past, there has been no handle structure which wassized and shaped to accommodate engagement by a user's hand disposed inits natural position with the palm facing the user. Nor has there beenany progressive funnel structure which would facilitate the introductionof instrumentation into the working channel of the sheath.

SUMMARY OF THE INVENTION

These deficiencies of the prior art have been eliminated with thepresent access device which includes a sheath having at its proximal enda handle specifically adapted to inhibit migration and facilitate usewith instrumentation. The handle is formed as a radial enlargementhaving a distally-facing surface and a proximally-facing surface. Thedistally-facing surface has a generally concave configuration whichprovides a gradual enlargement inhibiting migration of the sheath intothe ureter. The concave configuration is sized to receive adjacentfingers of a user's hand disposed in its natural position, in order tofacilitate the stationary orientation of the sheath. The concave,distally-facing surface is continuous around the axis of the sheath sothat the advantage of this concave configuration can be appreciatedregardless of the radial orientation of the sheath.

The proximal-acing surface has a generally convex configurationproviding for an increased funneling of an instrument as it is insertedinto the working channel of the sheath. Both the distally-facing surfaceand the proximally-facing surface extend radially inwardly withprogressively equal distal positions along the sheath. This provides thehandle with the general shape of the bell of a horn. This configurationis not only ergonomically comfortable, but highly practical inaddressing the problems of migration, as well as instrument insertionand removal.

The handle can be provided with characteristics permitting the handle tobe moved to a preferred position along the tube of the sheath, and thento be fixed to the tube at that preferred location. This makes itpossible to provide the sheath with any desired length, even after ithas been inserted into the body conduit. A metal structure such as aspring, can be molded into the tube of the sheath to facilitate kinkresistance.

The inner dilator can be provided with a Luerlock end, permittingattachment of a sidearm adaptor (not shown). This allows forinstallation of contrast during sheath placement without the need toremove the guidewire.

These and other features and advantages of the invention will becomemore apparent with a description of preferred embodiments and referenceto the associated drawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a sheath of the presentinvention with an obturator or dilator adapted for use with the sheath;

FIG. 2 is a perspective view illustrating the obturator operativelydisposed within the sheath;

FIG. 3 is an axial cross-section view taken along lines 3-3 of FIG. 2and illustrating the obturator operatively disposed within a tube and“handle” of the sheath;

FIG. 4 is an enlarged radial cross-section view of the handle assemblyillustrated in FIG. 3;

FIG. 5 is a side-elevation view of the sheath and obturator operativelydisposed in the urethra and illustrating a preferred configuration forthe handle assembly of the sheath;

FIG. 6 is a side-elevation view similar to FIG. 5 of a furtherembodiment of the handle assembly of the present invention;

FIG. 7 is a side-elevation view partially in phantom and exploded toillustrate components of another preferred embodiment of the handleassembly providing for sheath length adjustment;

FIG. 8 is a side-elevation view illustrating the components of FIG. 7 inan assembled configuration;

FIG. 9 is a radial cross-section view taken along lines 9-9 of FIG. 8;

FIG. 10 is a perspective, disassembled view of a further embodiment of ahandle assembly permitting length adjustment;

FIG. 11 is a perspective, assembled view of the components illustratedin FIG. 10; and

FIG. 12 is a side-elevation view partially in fragment and illustratinga spring embodiment of the tube associated with the sheath of thepresent invention.

DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

A ureteral access sheath is illustrated in FIG. 1 and designatedgenerally by the reference numeral 10. In FIG. 1, the sheath 10 isillustrated in combination with a separate, but associated, dilator orobturator 12. The sheath 10 has the general configuration of an elongatetube 14 having an axis 16 which extends between a proximal end 18 and adistal end 21. A handle 23 is disposed at the proximal end 18 of thetube 14 and provides access into a working channel 25 of the tube 14.

The obturator 12 will typically have the configuration of an elongaterod 30 extending between a proximal end 32 and a distal end 34. A knob36 is disposed at the proximal end 32 and a tapered tip 38 is formed atthe distal end 34. The obturator 12 is adapted to be inserted into theworking channel 25 of the sheath 10 with the knob 36 extendingproximally of the sheath 10, and the distal end 34 extending distally ofthe sheath 10. This operative position of the obturator 12 within thesheath 10 is illustrated in the assembled view of FIG. 2. An axialcross-section view of the assembled combination is illustrated in FIG. 3where the rod 30 of the obturator 12 is more clearly shown within theworking channel 25 of the sheath 10.

If desired, the releasable lock (not shown) can be provided to removablyattach the obturator 12 to the sheath 10. When locked in place, theobturator 12 and sheath 10 can then be passed as a single unit over theguidewire. This arrangement precludes inadvertent advancement of thesheath 10 in front of the obturator 12, which could greatly impedeproper passage of the sheath and potentially the ureter.

The handle 23 associated with the sheath 10 is of particular interest tothe invention and is illustrated in the enlarged, axial cross-sectionview of FIG. 4. From this view it can be seen that the handle 23 has thegeneral configuration of the bell of a horn. The handle 23 has adistally-facing surface 41 on the outside of the handle 23, and aproximally-facing surface 43 on the inside of the handle 23. Both ofthese surfaces 41 and 43 in the preferred embodiment are continuous andhave a generally conical configuration. In the illustrated embodiment,the distally-facing surface 41 is generally concave, while theproximally-facing surface 43 is generally convex.

The handle 23 can be provided with two small holes 45, 46 for passage ofsutures 47 and 48, respectively. Once the sheath is in place, thesutures 47, 48 can be clamped with hemostats (not shown) to the surgicaldrapes, thereby preventing distal migration of the sheath and loss ofureteral access. Once the obturator/sheath combination has been advancedto the desired position in the ureter, the obturator 12 can be unlockedfrom the sheath 10 and removed. In the manner discussed in greaterdetail below, these features offer particular advantages to the presentinvention.

One of the purposes of the proximally-facing surface 43 is to funnel theobturator 12 and other surgical instrumentation into the working channel25 of the sheath 10. With the generally conical configuration, thisproximally-facing surface functions as a funnel with a radius whichdecreases with progressive distal positions along the axis 16. Thus, asthe instrumentation is moved distally, the proximally-facing surface 43guides the instrument along a decreasingly decreasing radius into theworking channel 25 of the sheath 10. Providing the surface 43 with agenerally convex configuration further facilitates this funnelingfeature of the invention. When the surface 43 is convex, its radiusdecreases at a decreasing rate with progressively equal distal positionsalong the axis 16.

The distally-facing surface 41 is intended to facilitate engagement ofthe sheath 10 by a user's hand held in its most natural state. In FIG.5, adjacent fingers 50 and 52 of the user's hands are illustratedschematically by the circles 50 and 52. In the natural state, the palmof the user's hands would be facing the user in the proximal direction,to the left in FIG. 5. The sheath 10 is adapted to be operativelypositioned between the fingers 50 and 52 with the handle 23 positionedso that the distally-facing surface 41 is in juxtaposition to thefingers 50 and 52. This fit is facilitated by forming the surface 41with a size and configuration generally similar to the fingers 50 and52, as illustrated in FIG. 5. Thus, with the distally-facing surface 41having a generally conical configuration, it has a radius whichdecreases with progressive distal positions along the axis 16. In anembodiment wherein the surface 41 is also concave, the radius of thesurface 41 decreases at a decreasing rate with progressively equaldistal positions along the axis 16.

In operation, as the surgical instrument, such as the obturator 12, isinserted into the handle 23, it produces a force F₁ (illustrated byarrow 54) in the distal direction. This force is opposed by the fingers50 and 52, which engage the distally-facing surface 43 and applyopposing forces F₂ and F₃ (represented by arrows 56 and 58). In thismanner, the fingers 50 and 52 can maintain the sheath 10 generallystationary even when the obturator 12 is being inserted. It will also benoted that with the user's hand in the natural position, it tends toform a barrier which prevents any instrumentation from extendingexteriorly beyond the handle 23 into contact with ureteral tissue 60.

Although the embodiment of FIG. 5 is particularly adapted to facilitateinsertion of a surgical instrument, such as the obturator 12, it will beappreciated that removal of the instrument also creates withdrawalforces on the sheath 10. A further embodiment of the handle which caneasily accommodate not only insertion forces but also withdrawal forces,is illustrated in FIG. 6. In this embodiment, a handle 61 is similar tothe handle 23, except that the outer, distally-facing surface 43 iscurved distally outwardly to form a proximally-facing outer surface 63.In this case, the two surfaces 41 and 63 form a continuous surface whichdefines an annular recess sized and configured to receive the fingers 50and 52.

In this embodiment, insertion of the instrument, such as the obturator12, is resisted by the forces F₂ and F₃ applied by the fingers 50 and52, respectively, to the distally-facing surface 43, as previouslydiscussed with reference to FIG. 5. In a similar manner, when theinstrument such as the obturator 12 is withdrawn, it produces a force F₄(illustrated by arrow 65) which must be resisted in order to maintainthe sheath 10 stationary. This resistance is provided in the embodimentof FIG. 6 by the pressure of the fingers 50, 52 against theproximally-facing outer surface 63. Thus, fingers 50, 52 provideopposing forces F₅ and F₆ designated by arrows 67, 70, respectively.

FIGS. 7-9 illustrated a further embodiment involving a handle, such asthe handles 23 or 61, which is movable relative to the tube 14 of thesheath 10. This embodiment is particularly desirable as it permits thetube 14 to be cut in situ, at the operative site, to a preferred length.With a sheath of this type, only a single access device need be presentat the operative site. Multiple sheaths having different lengths are notrequired to be present in order to have a sheath of the desired length.As illustrated in FIG. 7, this embodiment of the sheath 10 includes thetube 14 which is slidingly engageable by a handle assembly 72 thatincludes a sleeve 74 and a funnel 76. The sleeve 74 is formed as acylinder 77 having an interior bore 78 and external threads 81. Anelastomeric element 83 is disposed within the bore 78 and is providedwith an axial lumen 84 appropriately sized to receive the tube 14.

The funnel 76 is formed similar to the handle 23, but includes twoconcentric cylinders 85 and 87 which extend distally. The outer cylinder85 is provided with interior threads 90, which are sized to receive theexternal threads 81 of the sleeve 74. The inner cylinder 87 of thefunnel 76 is provided with an outer diameter less than the innerdiameter of the bore 78. This inner cylinder 87 extends to a distalsurface 92.

In operation, the funnel 76 is moved axially over the sleeve 74 and theinternal threads 90 are screwed onto the external threads 81. Furtherrotation of the funnel 76 relative to the sleeve 74, causes the distalsurface 92 of the inner cylinder 87 to axially compress the elastomericelement 83. This compression causes the element 83 to expand inwardlydecreasing the diameter of its lumen 84 and thereby increasing thefrictional engagement of the handle assembly 72 relative to the tube 14.

In order to provide the sheath 10 with a desired length, the tube 14 canbe cut to a predetermined length, either before or after mounting thehandle assembly 72 on the tube 14 Axial movement of the handle assembly72 to a desired proximal location on the tube 14 provides the sheath 10with the desired length. Operation of the handle 72 in the mannerpreviously discussed will fix the assembly 72 on the tube 14 at thisdesired location.

In another embodiment illustrated in FIG. 10, a movable handle assembly96 includes a funnel 98 similar to the handle 23. It also includes acylinder 99 which extends distally within portions 101 which have areduced diameter. A separate finger clamp 102 includes a cylinder 104which has a diameter which is dependent upon operation of finger tabs103 and 105. When these tabs 103 and 105 are compressed, the cylinder104 has a relatively large diameter. When the tabs 103 and 105 are notcompressed, the cylinder 104 is biased toward a reduced diameter. Thisfinger clamp 102 is intended to be operatively disposed over the thinportions 101 of the cylinder 99, as illustrated in FIG. 11. In thisoperative position, the entire handle assembly 96 can be moved along thetube 14 by compressing the finger tabs 103 and 105 of the clamp 102. Thetube 14 can then be cut, for example, with scissors 106, to any desiredlength. Compressing the finger tabs 103 and 105 will permit the handleassembly 96 to be moved to a distal position, as illustrated in FIG. 11,where the tabs 103 and 105 can be released to compress the thin portions101 and maintain the handle assembly 96 in a fixed relationship with thetube 14.

A further embodiment of the invention is illustrated in the side-view ofFIG. 11. In this embodiment, the tube 14 is formed with an inner plasticbody 110, surrounded by a metal spring coil 112, which is furthercovered by an outer body 114. This particular embodiment of the tube 14provides a high degree of kink resistance and can be used with any ofthe handle assemblies previously discussed. With this embodiment of thetube 14, the inner body 110 provides a smooth surface within the sheath10, which facilitates passage of instrumentation. The spring coil 112adds kink resistance to the tube 14, while the outer body 114 provides asuitable covering for the coils of the spring 112.

From the foregoing description of preferred embodiments, it will beapparent that many variations on the concept of this invention will becontemplated by those skilled in the art. For example, many differentconfigurations of the tube 14 can be used with the various handleassemblies disclosed. Furthermore, the handle assemblies can be embodiedin many different forms to provide at least one curved outer surfacewhich is sized and configured to receive the fingers of a user's hand ina normal position. The fact that this desired outer shape can becombined with a funnel configuration at the proximal end of the sheath,will add further advantages to these various embodiments.

Although exemplary embodiments of the invention have been shown anddescribed, many other changes, modifications, and substitutions will nowbe apparent to those of ordinary skill in the art, without necessarilydeparting from the spirit and scope of this invention as set forth inthe following claims.

1. A ureteral access sheath adapted for insertion into a urethra havinga diameter D₁, the access sheath being adapted for use by a personhaving a pair of adjacent fingers, the access sheath comprising: anelongate tube being formed of a bio-compatible material and having adiameter D₂ and a lumen extending between a proximal end and a distalend, the diameter D₂ being smaller than the diameter D₁ of the urethra;a first handle being formed of a bio-compatible material and disposed atthe proximal end of the tube; portions of the first handle extendingradially outwardly of the tube to provide the first handle with adiameter D₃ that is greater than the diameter D₁ of the urethra, thehandle portions being defined by a first surface facing generallydistally and a second surface facing generally proximally; and a secondhandle being formed of a bio-compatible material and disposed distallyof the first handle, the second handle including a third surface facinggenerally proximally, wherein the first surface and the third surfaceare concave, continuous and both sized and configured to receive theadjacent fingers of the user, wherein the first surface is continuouswith the third surface so as to define an annula recess, wherein thesecond surface is convex so as to form a funnel leading into the lumenof the tube, whereby the handle portions inhibit distal migration of theproximal end of the tube into the urethra.
 2. The access sheath recitedin claim 1, wherein the second surface extends decreasingly radiallyinwardly with progressive equal distal positions along the tube.
 3. Theaccess sheath recited in claim 2, wherein the first surface extendsdecreasingly radially inwardly with progressive equal distal positionsalong the tube.
 4. (canceled)
 5. A handle adapted for use with asurgical access device having an elongate tube with a working channeland an axis, the handle comprising: a distally facing, concave surfacedefining radii which decrease at a decreasing rate with progressivelyequal distal positions along the axis; a first proximally facing, convexsurface that is substantially parallel to the distally facing, concavesurface; and a second proximally facing, concave surface distal to thedistally facing, concave surface, the second proximally facing, concavesurface being continuous with the distally facing, concave surface todefine an annular recess, wherein the tube and the handle are formedfrom a bio-compatible material.
 6. The handle recited in claim 5,wherein the distally facing surface is curved substantially throughoutits entirety.
 7. The handle assembly recited in claim 6, wherein thefirst proximally facing surface is curved substantially throughout itsentirety.
 8. A ureteral access sheath, comprising: an elongate tubehaving a lumen extending between a proximal end and a distal end; ahandle disposed at the proximal end of the tube having a flaredconfiguration, a first surface facing generally distally, and a secondsurface facing generally proximally, wherein the second surface extendsdecreasingly radially inwardly with progressive equal distal positionsalong the tube.
 9. The ureteral access sheath of claim 8, wherein thefirst surface is concave.
 10. (canceled)
 11. The ureteral access sheathof claim 8, wherein the first surface is convex.
 12. (canceled) 13.(canceled)
 14. The ureteral access sheath of claim 8, wherein the tubeprovides a smooth surface to facilitate passage of the instrument. 15.(canceled)
 16. The ureteral access sheath of claim 8, wherein theinstrumentation includes an obturator comprising an elongate rodextending between a proximal end and a distal end.
 17. The ureteralaccess sheath of claim 16, wherein the obturator further includes areleasable mechanism disposed at the proximal end of the elongate rodthat is removably attachable to the handle.
 18. The ureteral accesssheath of claim 17, wherein the attachment of the obturator to thesheath precludes inadvertent advancement of the sheath in front of theobturator. 19.-25. (canceled)
 26. A ureteral access sheath, comprising:an elongate tube having a lumen extending between a proximal end and adistal end; a first handle disposed at the proximal end of the tube, thefirst handle being defined by a first surface facing generally distallyand a second surface facing generally proximally; a second handledisposed distally of the first handle, the second handle including athird surface facing generally proximally; wherein the first surface iscontinuous with the third surface so as to define an annular recess, andthe second surface is convex so as to form a funnel leading into thelumen of the tube.
 27. (canceled)
 28. The ureteral access sheath ofclaim 26, wherein the tube provides a smooth surface to facilitatepassage of an instrument.
 29. (canceled)
 30. The ureteral access sheathof claim 28, wherein the instrumentation includes an obturatorcomprising an elongate rod extending between a proximal end and a distalend.
 31. The ureteral access sheath of claim 30, wherein the obturatorfurther includes a releasable mechanism disposed at the proximal end ofthe elongate rod that is removably attachable to the handle.
 32. Theureteral access sheath of claim 31, wherein the attachment of theobturator to the sheath precludes inadvertent advancement of the sheathin front of the obturator.
 33. The ureteral access sheath of claim 1,the elongate tube comprising a flexible elongate tube.
 34. The ureteralaccess sheath of claim 1, wherein the handle portions, in conjunctionwith the adjacent fingers of the user, maintain the tube substantiallystationary.
 35. The ureteral access sheath of claim 5, the elongate tubecomprising a flexible elongate tube.
 36. The ureteral access sheath ofclaim 5, wherein the handle maintains the tube substantially stationary.37. A ureteral access sheath adapted for insertion into a urethra havinga diameter D₁, the access sheath being adapted for use by a personhaving a pair of adjacent fingers, the access sheath comprising: aflexible elongate tube being formed of a bio-compatible material andhaving a diameter D₂ and a lumen extending between a proximal end and adistal end, the diameter D₂ being smaller than the diameter D₁ of theurethra; a first handle being formed of a bio-compatible material anddisposed at the proximal end of the tube; portions of the first handleextending radially outwardly of the tube to provide the first handlewith a diameter D₃ that is greater than the diameter D₁ of the urethra,the handle portions being defined by a first surface facing generallydistally and a second surface facing generally proximally; and a secondhandle being formed of a bio-compatible material and disposed distallyof the first handle, the second handle including a third surface facinggenerally proximally, wherein the first surface and the third surfaceare concave, continuous around an axis of the tube, and both sized andconfigured to receive the adjacent fingers of the user, wherein thefirst surface is continuous with the third surface so as to define anannular recess, wherein the second surface is convex so as to form afunnel leading into the lumen of the tube, whereby the handle portionsinhibit distal migration of the proximal end of the tube into theurethra, wherein the handle portions, in conjunction with the adjacentfingers of the user, maintain the tube substantially stationary.
 38. Theaccess sheath recited in claim 37, wherein the second surface extendsdecreasingly radially inwardly with progressive equal distal positionsalong the tube.
 39. The access sheath recited in claim 38, wherein thefirst surface extends decreasingly radially inwardly with progressiveequal distal positions along the tube.